Clinical trial · Interventional
T Cell Receptor-transduced T Cells Targeting NY-ESO-1 for Treatment of Patients With NY-ESO-1- Expressing Malignancies
Phase I Study of Malignancies That Express NY-ESO-1 With T Cell Receptor-transduced T Cells Targeting NY-ESO-1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Autologous T cells engineered to express a T cell receptor (TCR) targeting NY-ESO-1 will be infused back to patients with NY-ESO-1- expressing malignancies. The patients pretreated with a lymphodepleting preconditioning regimen will be monitored after infusion of anti-NY-ESO-1 TCR-transduced T cells for adverse events, persistence of anti-NY-ESO-1 TCR-transduced T cells and treatment efficacy. Objectives: To evaluate the safety and the efficacy of anti-NY-ESO-1 TCR-transduced T cell-based immunotherapy for patients with NY-ESO-1- expressing malignancies. Eligibility: Patients older than one year of age, who have relapsed or refractory malignancies that express both NY-ESO-1 and human leukocyte antigen (HLA)-A2 molecules. Patients must have adequate organ functions. Design: * Peripheral blood from patients will be collected for isolation of peripheral blood mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector encoding an HLA-A2 restricted anti-NY-ESO-1 TCR gene. * Patients will receive a lymphodepleting preconditioning regimen to prepare their immune system to accept modified T cells. * Patients will receive an infusion of their own modified T cells. They will remain in the hospital to be monitored for adverse events until they have recovered from the treatment. * Patients will have frequent follow-up visits to monitor the persistence of modified T cells and efficacy of the treatment.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Esophagus Carcinoma | Esophageal Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Other Metastatic Solid Cancers | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-NY ESO-1 TCR-transduced T cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-NY ESO-1 TCR-transduced T cells
- description
- Patients will receive a lymphodepleting conditioning regimen followed by an infusion of anti-NY-ESO-1 TCR-transduced T cells.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Biological: Anti-NY ESO-1 TCR-transduced T cells
Primary outcomes (1)
- measure
- Number of participants with Adverse Events
- timeFrame
- 8 weeks
- description
- To evaluate the safety and feasibility of the administration of anti-NY-ESO-1 TCR transduced T cells in patients with HLA-A2+ NY-ESO-1-expressing malignancies.
Secondary outcomes (1)
- measure
- Number of participants with Clinical responses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
* Inclusion Criteria: 1. Must be pathology or cytology confirmed cancer patients with age of one year old and over; 2. Must be HLA-A2 positive, and cancer tissues express NY-ESO-1; 3. There is at least one measurable disease: diameter ≥20mm or spiral CT≥10mm; 4. Willing to sign a durable power of attorney; 5. Able to understand and sign the Informed Consent Document; 6. Performance status:ECOG 0-2; 7. Life expectancy:More than 3 months; 8. Patients must be willing to practice birth control for four months after receiving a lymphodepleting preconditioning regimen; 9. Patients with no pregnancy and lactation; 10. Hematopoietic: (1) Absolute neutrophil count \> 1000/mm3 without support of filgrastim; (2) Platelet count \> 100,000/mm3; (3) Hemoglobin \> 8.0 g/dL; (4) lymphocyte count \>500/mm3; (5) WBC \> 3,000/mm3; 11. Chemistry: (1) AST and ALT \< 2.5 times upper limit of normal; (2) Serum creatinine≤1.6 mg/dl; (3) Bilirubin ≤1.5 mg/dL(3.0 mg/dL in patients with Gilbert's syndrome); 12. Seronegative for hepatitis B and C viruses; 13. Seronegative for human immunodeficiency virus (HIV) antibody; 14. More than four weeks must have elapsed since any prior systemic therapy at the time of randomization, and patients' toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo). Patients may have undergone minor surgical procedures within the past 3 weeks, as long as all toxicities have recovered to grade 1 or less or as specified in the eligibility criteria; 15. Six weeks must have elapsed since any prior anti-CTLA4 antibody therapy to allow antibody levels to decline. Patients who have previously received any anti-CTLA4 antibody and have documented gastrointestinal (GI) toxicity must have a normal colonoscopy with normal colonic biopsies. * Exclusion Criteria: 1. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease); 2. Active systemic infections; 3. Coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; 4. Concurrent use of systemic steroids; 5. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 6. There are obvious dysfunctions in heart , liver,kidney and other vital organs 7. T cell lymphoma and leukemia patients; 8. HIV positive; 9. History of coronary revascularization or ischemic symptoms; 10. Documented Left Ventricular Ejection Fraction (LVEF) of less than or equal to 45 percent tested in patients with: Clinically significant atrial and/or ventricular arrhythmias including but not limited to: atrial fibrillation, ventricular tachycardia, second or third degree heart block; 11. Documented forced expiratory volume 1 (FEV1) less than or equal to 60 percent predicted tested in patients with a prolonged history of cigarette smoking (20 pk/yrs of smoking) or symptoms of respiratory dysfunction; 12. Bronchial lesions (probably shifted obstructive pneumonia or intracranial hemorrhage risk)
References
Publications (0)
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